WithdrawnEarly Phase 1

Dopamine Rhythms in Health and Addiction

Stopped: No enrollment, delay with drug availability.

United States0Started 2024-04-23

Plain-language summary

Background: \- Dopamine is a chemical signal linked to the rewarding effects of drugs. Certain genes make these effects sensitive to the time of day they are taken. Cocaine can affect these genes in the brain. Researchers want to measure brain dopamine at different times of day. Objectives: \- To look for changes to a person s biological clock in the function of the dopamine reward system. To test if cocaine disrupts this. Eligibility: * Adults age 21-55 with a cocaine use disorder. * Healthy volunteers age 21-55. Design: * Participants will be screened with medical history, physical exam, interview, and blood and urine tests. Their breath will be tested for alcohol and recent smoking. * Participants will have 3 overnight clinic visits. * Visit 1: They will have blood and urine collected and a heart test. * A plastic tube (catheter) will be placed into a vein in each arm by needle. * Participants will have a PET scan in a donut-shaped machine. They will lie on a bed that slides in and out of it, wearing a cap. A radiotracer (measures dopamine) and a drug (blocks dopamine removal) will be injected via catheter. Vital signs will be measured and blood will be drawn throughout. * Visit 2: repeats Visit 1, except at night. * Visit 3, participants will have urine collected. * They will have MRI scans in a metal cylinder surrounded by a magnetic field. They will lie on a table that slides in and out of it, with a coil over their head. * Participants may answer questions, take computer or paper tests, and perform simple actions. * For 1 week, participants will wear a wrist device that measures daily activity.

Who can participate

Age range

21 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Between 21 and 55 years of age.
. Ability to provide written informed consent.
. DSM-IV or DSM-5 diagnosis of a moderate or severe cocaine use disorder established through history and clinical exam.
. Non-treatment seeking cocaine users (actively consuming cocaine - last use within one week of study as assessed by self-reports).
. Minimum 10 years history of cocaine abuse predominantly via smoking or injection - self-report.
. Must consume at least 4 grams of cocaine per week - self-report.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To determine if there is disruption in circadian rhythms in cocaine use disorder (CUD) as compared to healthy controls.

Timeframe: end of study

Trial details

NCT IDNCT02233829

SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2024-04-23

View on ClinicalTrials.gov More Cocaine Abuse trials